UMIN-ICDS 臨床試験登録情報の閲覧

UMIN試験ID UMIN000032594
受付番号 R000037153
科学的試験名
一般公開日(本登録希望日) 2018/05/14
最終更新日 2022/11/16 09:46:30

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information

一般向け試験名/Public title

日本語


英語
The Effects of Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being: A Study among Malaysian Muslim Students

一般向け試験名略称/Acronym

日本語


英語
Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being

科学的試験名/Scientific Title

日本語


英語
The Effects of Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being: A Study among Malaysian Muslim Students

科学的試験名略称/Scientific Title:Acronym

日本語


英語
Nature Connectedness and Spiritual Practice of Dhikr on Psychological and Physical Well-Being

試験実施地域/Region

アジア(日本以外)/Asia(except Japan)


対象疾患/Condition

対象疾患名/Condition

日本語


英語
Healthy individual

疾患区分1/Classification by specialty

該当せず/Not applicable 成人/Adult

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

はい/YES


目的/Objectives

目的1/Narrative objectives1

日本語


英語
To study the effects of nature connectedness and spiritual practice of Dhikr in influencing the psychological and physiological well-being of Malaysian Muslim students.

目的2/Basic objectives2

その他/Others

目的2 -その他詳細/Basic objectives -Others

日本語


英語
1. To examine the levels and patterns of psychological well-being (intensity of emotional stress responses), ecopsychological and spiritual values, as well as physiological measures of stress (blood pressure, salivary cortisol and alpha-amylase) among Malaysia Muslim students.
2. To study the effects of indoor and outdoor green exposure on the levels of psychological well-being, ecopsychological and spiritual values, as well as physiological measures of stress among Malaysia Muslim students.
3. To study the effects of spiritual practice of Dhikr in both indoor and outdoor environments on the levels of psychological well-being, ecopsychological and spiritual values, as well as physiological measures of stress among Malaysia Muslim students.
4. To realise the manipulation of body functions through differential gene expression patterns following indoor and outdoor green exposure, with or without the spiritual practice of Dhikr.

試験の性質1/Trial characteristics_1

探索的/Exploratory

試験の性質2/Trial characteristics_2

実務的/Pragmatic

試験のフェーズ/Developmental phase

該当せず/Not applicable


評価/Assessment

主要アウトカム評価項目/Primary outcomes

日本語


英語
The difference in the levels of psychological well-being, ecopsychological and spiritual values pre- and post-experimental exposure

副次アウトカム評価項目/Key secondary outcomes

日本語


英語
The difference in blood pressure, salivary cortisol levels, salivary alpha amylase levels and blood gene expression pattern pre- and post-experimental exposure


基本事項/Base

試験の種類/Study type

介入/Interventional


試験デザイン/Study design

基本デザイン/Basic design

要因デザイン/Factorial

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

個別/Individual

ブラインド化/Blinding

オープン/Open -no one is blinded

コントロール/Control

無治療対照/No treatment

層別化/Stratification


動的割付/Dynamic allocation


試験実施施設の考慮/Institution consideration


ブロック化/Blocking


割付コードを知る方法/Concealment



介入/Intervention

群数/No. of arms

4

介入の目的/Purpose of intervention

教育・カウンセリング・トレーニング/Educational,Counseling,Training

介入の種類/Type of intervention

その他/Other

介入1/Interventions/Control_1

日本語


英語
Indoor exposure without spiritual practice of Dhikr

介入2/Interventions/Control_2

日本語


英語
Indoor exposure with spiritual practice of Dhikr

介入3/Interventions/Control_3

日本語


英語
Outdoor exposure without spiritual practice of Dhikr

介入4/Interventions/Control_4

日本語


英語
Outdoor exposure with spiritual practice of Dhikr

介入5/Interventions/Control_5

日本語


英語

介入6/Interventions/Control_6

日本語


英語

介入7/Interventions/Control_7

日本語


英語

介入8/Interventions/Control_8

日本語


英語

介入9/Interventions/Control_9

日本語


英語

介入10/Interventions/Control_10

日本語


英語


適格性/Eligibility

年齢(下限)/Age-lower limit

18 歳/years-old 以上/<=

年齢(上限)/Age-upper limit

23 歳/years-old 以下/>=

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語


英語
Malaysia Matriculation students;
Muslim,
BMI: 18.5-24.9;
Not taking any medication (including herbal medicine and supplement).

除外基準/Key exclusion criteria

日本語


英語
Malignancy, immunodeficiency, autoimmune disorders, hepatitis, hypertension, HIV infection, or smoking.

目標参加者数/Target sample size

160


責任研究者/Research contact person

責任研究者/Name of lead principal investigator

日本語

ミドルネーム


英語
Samsilah
ミドルネーム
Roslan

所属組織/Organization

日本語


英語
Universiti Putra Malaysia

所属部署/Division name

日本語


英語
Faculty of Educational Studies

郵便番号/Zip code

43300

住所/Address

日本語


英語
Faculty of Educational Studies, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.

電話/TEL

60389471413

Email/Email

samsilah@upm.edu.my


試験問い合わせ窓口/Public contact

試験問い合わせ窓口担当者/Name of contact person

日本語

ミドルネーム


英語
Samsilah
ミドルネーム
Roslan

組織名/Organization

日本語


英語
Universiti Putra Malaysia

部署名/Division name

日本語


英語
Faculty of Educational Studies

郵便番号/Zip code

43300

住所/Address

日本語


英語
Faculty of Educational Studies, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.

電話/TEL

60389471413

試験のホームページURL/Homepage URL

http://www.educ.upm.edu.my/

Email/Email

samsilah@upm.edu.my


実施責任個人または組織/Sponsor or person

機関名/Institute

日本語
その他


英語
Faculty of Educational Studies, Universiti Putra Malaysia

機関名/Institute
(機関選択不可の場合)

日本語


部署名/Department

日本語


個人名/Personal name

日本語


英語


研究費提供組織/Funding Source

機関名/Organization

日本語
その他


英語
Ministry of Education Malaysia

機関名/Organization
(機関選択不可の場合)

日本語


組織名/Division

日本語


組織の区分/Category of Funding Organization

その他の国の官庁/Government offices of other countries

研究費拠出国/Nationality of Funding Organization

日本語


英語
Malaysia


その他の関連組織/Other related organizations

共同実施組織/Co-sponsor

日本語


英語

その他の研究費提供組織/Name of secondary funder(s)

日本語


英語


IRB等連絡先(公開)/IRB Contact (For public release)

組織名/Organization

日本語


英語
The Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia

住所/Address

日本語


英語
The Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia, Research Management Centre, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.

電話/Tel

60389471244

Email/Email

dir.rmc@upm.edu.my


他機関から発行された試験ID/Secondary IDs

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1


ID発行機関1/Org. issuing International ID_1

日本語


英語

試験ID2/Study ID_2


ID発行機関2/Org. issuing International ID_2

日本語


英語

治験届/IND to MHLW



試験実施施設/Institutions

試験実施施設名称/Institutions



その他の管理情報/Other administrative information

一般公開日(本登録希望日)/Date of disclosure of the study information

2018 05 14


関連情報/Related information

プロトコル掲載URL/URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037153

試験結果の公開状況/Publication of results

未公表/Unpublished


結果/Result

結果掲載URL/URL related to results and publications

http://dx.doi.org/10.6007/IJARBSS/v12-i9/14784

組み入れ参加者数/Number of participants that the trial has enrolled

149

主な結果/Results

日本語


英語
The present findings support the stress-relieving effects following co-exposure to nature and dhikr meditation via improvements in both psychological and physiological well-being.

主な結果入力日/Results date posted

2019 06 25

結果掲載遅延/Results Delayed


結果遅延理由/Results Delay Reason

日本語


英語

最初の試験結果の出版日/Date of the first journal publication of results

2022 09 19

参加者背景/Baseline Characteristics

日本語


英語
Characteristic Outdoor Indoor
Dhikr Non-dhikr Dhikr Non-dhikr
Total participants (No.) 35 38 39 37
Gender
Male (No.) 17 17 26 19
Female (No.) 18 21 13 18
Body Mass Index (No.)
<18.5 kg m-2 4 3 4 4
18.5 to 24.9 kg m-2 29 33 35 29
> 25 kg m-2 2 2 3 4
Age (Years) 18-23
Religion
Islam (%) 100
Currently pregnant No
Smoking No
Currently taking medication No
Major health problem No

参加者の流れ/Participant flow

日本語


英語
Outdoor Indoor
Dhikr Non-dhikr Dhikr Non-dhikr
Started 35 38 39 37
Gender
Male (No.) 17 17 26 19
Female (No.) 18 21 13 18
Completed 35 38 39 37
Non-completed 0 0 0 0
Analysis 35 38 39 37

有害事象/Adverse events

日本語


英語
Not available

評価項目/Outcome measures

日本語


英語
Effects of exposure to nature greens and dhikr on profile of mood states
Profile of mood states (POMS) scores at pre- and post-exposure for all the different experimental settings are presented in Table 2. In brief, there were no significant differences at pre-experimental exposure, indicating that all the groups were initially equalled on mood disturbances by the randomization procedure. At post-experimental exposure, significant differences (p < 0.05) were observed for POMS scores on the subscales of tension, fatigue, confusion, vigor, calmness and total mood disturbances. Exposure to outdoor greenery environment positively influenced the mood of study participants in comparison to those exposed to the indoor environment. Similarly, the meditative-practice of dhikr, under both outdoor and indoor conditions, significantly improved POMS scores at post-exposure. Further analysis on the change scores, however, indicated that combination exposure to both nature and dhikr triggered greater decrease in mood disturbance on the subscales of tension, depression, anger, fatigue, confusion and total mood disturbances. In particular, the outdoor dhikr group recorded 44.44, 57.78 and 60.00% (p < 0.05) reduction in total mood disturbances when compared to the outdoor non-dhikr, indoor dhikr and indoor non-dhikr groups respectively.

Effects of exposure to nature and dhikr on ecopsychology and spiritual values
Exposure to nature and meditative-practice of dhikr differentially affected ecopsychology and spiritual values of the study participants. The data are shown in Table 3. At pre-experimental exposure, all the groups shared similar scores and were matched for both ecopsychology and spiritual values. Surprisingly, at post-experimental exposure, dhikr meditation in both outdoor and indoor environments significantly affected the ecopsychological values that seek to understand the emotional connection between an individual and the nature, but not spiritual values that confer reverence toward the universe. The outdoor dhikr and indoor dhikr groups respectively experienced 13.74 and 15.27% (p < 0.05) higher ecopsychological values in comparison to the indoor non-dhikr group. Further analysis on the change scores, however, demonstrated that the participants who were exposed to nature and dhikr meditation concurrently had a more positive impact on both ecopsychology and spirituality. The outdoor dhikr group recorded approximately 25.80- and 7.41-fold increase (p < 0.05) in ecopsychology and spiritual values respectively when compared to the indoor non-dhikr group. On the other hand, meditative practice of dhikr in an indoor environment demonstrated significant improvement in spirituality, approximately 34.46-fold increase (p < 0.05) in comparison to indoor non-dhikr group, but not in ecopsychology, essentially indicating effect of dhikr meditation even if modulatory on the nature exposure.


Pulse rate and blood pressure
Pulse rate and blood pressure measurements are shown in Table 4. Briefly, pulse rate remain stable throughout the whole experimental exposure across all the different environmental settings. The different exposures appeared not to have any significant effects on the parameter. In addition, there was also no significant difference in the systolic and diastolic blood pressure measurements at pre-experimental exposure. Nevertheless, significant changes in systolic blood pressure measurements were observed after the experimental procedure. In comparison to the other groups at post-experimental exposure, the outdoor non-dhikr recorded the lowest (p < 0.05) systolic blood pressure.

Saliva cortisol and alpha amylase
The salivary stress markers levels are depicted in Figure 2. In accordance with the psychological measurements findings, there were no significant differences in the salivary cortisol and alpha amylase levels at the beginning of the study. Significant reductions in the salivary cortisol levels were observed post-experimental exposure. The outdoor dhikr, outdoor non-dhikr and indoor dhikr groups respectively recorded 34.75, 43.94 and 31.86% (p < 0.05) reduction in salivary cortisol levels when compared to the indoor non-dhikr group. Collectively, the results suggest an all-or-none effect on saliva cortisol level when exposed to nature and dhikr at the same time. Change scores revealed that both outdoor groups experienced greater reduction in the salivary cortisol levels in comparison to the indoor groups. Significant reductions ranging between 4.51- to 7.14-fold (p < 0.05) were observed.

On the other hand, the salivary alpha amylase levels increased slightly for both indoor groups at post-experimental exposure. In comparison to the outdoor dhikr and outdoor non-dhikr groups, the indoor dhikr group recorded 2.08- and 1.92-fold (p < 0.05) increase while the indoor non-dhikr groups recorded 1.38- and 1.28-fold (p < 0.05) increase respectively in the enzyme levels. The meditative-practice of dhikr did not affect the salivary alpha amylase stress response under both outdoor and indoor settings. In addition, the change scores were also not significantly different among the four different experimental groups.

個別症例データ共有計画/Plan to share IPD

日本語


英語
No

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語


英語
There is not a plan to make IPD available.


試験進捗状況/Progress

試験進捗状況/Recruitment status

参加者募集終了‐試験継続中/No longer recruiting

プロトコル確定日/Date of protocol fixation

2017 07 19

倫理委員会による承認日/Date of IRB

2017 07 19

登録・組入れ開始(予定)日/Anticipated trial start date

2017 09 23

フォロー終了(予定)日/Last follow-up date

2017 11 30

入力終了(予定)日/Date of closure to data entry

2018 12 31

データ固定(予定)日/Date trial data considered complete

2018 12 31

解析終了(予定)日/Date analysis concluded

2022 09 19


その他/Other

その他関連情報/Other related information

日本語


英語


管理情報/Management information

登録日時/Registered date

2018 05 14

最終更新日/Last modified on

2022 11 16



閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000037153


英語
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037153


研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名